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NCT02233959 · ClinicalTrials.gov registry record
Palatability of a Novel Oral Formulation of Prednsione
A clinical trial, sponsored by Arkansas Children's Hospital Research Institute.
- Completed
- Registry status
- 24
- Enrollment target
NCT02233959: Completed study, sponsored by Arkansas Children's Hospital Research Institute.
NCT02233959 is a clinical trial that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02233959 has completed, sponsored by Arkansas Children's Hospital Research Institute.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
Study Summary
Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.
Primary Outcome
We will create optimized shelf-stable prednisone microcapsules designed for complete taste-masking followed by immediate release in the stomach. Release characteristics of the TP will be compared to a pharmaceutical grade formulation of prednisone. Milestone: Microencapsulated prednisone that: (i) shows less than 10% coefficient of variance (CV) in the in vitro release profile between fresh and 4-week, 40°C stability-exposed samples while maintaining (ii) maximum of 5% total drug release during
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-01 |
What the finished NCT02233959 record still lists
NCT02233959 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02233959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02233959 about?
NCT02233959 is a clinical study titled "Palatability of a Novel Oral Formulation of Prednsione". Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation ...
What is the current status of trial NCT02233959?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2015-12. Estimated completion is 2016-01.
Who is sponsoring clinical trial NCT02233959?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
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